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| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00232557 |
Purpose
This project is investigating whether application of a telecommunications system to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak-flow-based action plans.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Device: Telephone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effectiveness of a Telecommunications System in Asthma Management |
| Estimated Enrollment: | 170 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Telephone-based home education and asthma monitoring
|
Device: Telephone
Telephone-based system designed to improve asthma self-management by enhancing compliance with preventive medication regimens
|
|
2: Active Comparator
Telephone-based home education
|
Device: Telephone
Telephone-based system designed to improve asthma self-management by enhancing compliance with preventive medication regimens
|
Background/Rationale:
Asthma is one of the most common chronic diseases of adults, affecting 6% of the U.S. adult population and accounting for substantial morbidity and mortality. Despite the availability of effective therapy for asthma, morbidity and mortality have increased over the last several decades. Asthma specialty care, case management, and patient education are means for improving the quality of asthma care and patient outcomes, but cost and inconvenience limit the degree to which these are used in asthma care nationally. The principal aim of this study is to evaluate the impact of an inexpensive telephone-based home education and disease monitoring system on asthma medication adherence and clinical outcomes in adult patients with asthma.
Objective(s):
We hypothesize that application of TLC to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak flow-based action plans. This, in turn, will improve asthma control, thus reducing acute health care utilization and improving quality of life (QOL).
Methods:
A randomized controlled trial will be conducted with adult asthma patients identified from the VA Boston Healthcare System comprised of the Boston, West Roxbury, and Brockton VA Medical Centers and their associated satellite clinics. Patients will be randomized to either the TLC-Asthma group or an attention placebo control group. Outcome measurements will include medication adherence, QOL, utilization of urgent care services, oral corticosteroid use
Status:
Ongoing
Impact:
OngoingTelephone-Linked Communications (TLC) systems offer an effective, low-cost, and easy-to-use means of providing ongoing education, behavioral counseling, and monitoring of clinical status.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
N/A
Contacts and Locations| United States, Massachusetts | |
| VA Boston Health Care System | |
| Boston, Massachusetts, United States, 02130 | |
| Principal Investigator: | David William Sparrow, DSc | VA Boston Health Care System |
More Information
| Responsible Party: | Department of Veterans Affairs ( Sparrow, David - Principal Investigator ) |
| Study ID Numbers: | IIR 01-054 |
| Study First Received: | September 30, 2005 |
| Last Updated: | November 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00232557 |
| Health Authority: | United States: Federal Government |
|
Asthma Disease Management Telecommunications |
Health Services Quality of Life Patient Compliance |
|
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Quality of Life Asthma Respiratory Hypersensitivity |
|
Immune System Diseases Bronchial Diseases |
